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DECREE No

DECREE No.46-CP OF AUGUST 6, 1996 OF THE GOVERNMENT ON SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS IN THE FIELD OF STATE MANAGEMENT OVER PUBLIC HEALTH

THE GOVERNMENT

Pursuant to the Law on Organization of the Government of September 30, 1992;

Pursuant to the Law on the Protection of the People�s Health of June 30, 1989;

Pursuant to the Ordinance on the Handling of Administrative Violations of July 6, 1995;

At the proposal of the Minister of Health,

DECREES:

Chapter I

ADMINISTRATIVE VIOLATIONS IN THE FIELD OF PUBLIC HEALTH, FORMS AND LEVELS OF SANCTION

Section A - ADMINISTRATIVE VIOLATIONS OF THE HYGIENE REGULATIONS; FORMS AND LEVELS OF SANCTION

Article 1.- Violations of the regulations on hygiene of food, foodstuffs, beverages, liquors and smoking stuffs:

1. Warning or a fine of 20,000 to 50,000 VND for one of the following acts:

a) Persons whose work is directly related to the processing, production of food products, foodstuffs, drinks of various kinds, liquors and smoking stuffs, but who fail to observe the regulations on personal hygiene or contract infectious diseases or skin diseases or have no training certificates in food hygiene and safety.

b) Failing to cover or pack cooked foods, instant food and drinks.

2. A fine of 200,000 to 800,000 VND for one of the following acts:

a) Failing to observe the regulations on ambient and tool hygiene at the places of production, processing, preservation, trading and transport of food products, foodstuffs, beverages and liquors.

b) Using materials, food additives and water not up to hygiene standard, for the production of food products, foodstuffs, beverages, liquors and smoking stuffs.

c) Establishments producing and trading in food products, foodstuffs, beverages, liquors and smoking stuffs having no certificates of food safety and hygiene or failing to renew their already expired certificates.

d) Producing and/or trading in food products, foodstuffs, beverages, liquors and smoking stuffs, which must be packed but are not labeled or improperly labeled.

e) Producing and/or trading in food products, foodstuffs, beverages, liquors and smoking stuffs without registration of food safety and hygiene.

f) Retailing on the market farm products with a residue of pesticide or chemical fertilizer thereon exceeding the allowed limits.

g) Trading in expired foodstuffs, beverages, liquors and smoking stuffs or failing to ensure hygiene standards.

3. A fine of 1,000,000 to 3,000,000 VND for one of the following acts:

a) Using chemical sugar (sweetener), coloring matters and other additives in the production and processing of foods, foodstuffs, beverages, liquors and smoking stuffs outside the list issued by the Ministry of Health.

b) Transporting for the purpose of consuming or trading meats of poultry and cattle affected by infectious diseases.

c) Manufacturing dining tools, containers for food products, foodstuffs, drinks, liquors and smoking stuffs from new materials and additives without certificates of quality control issued by the competent health agency.

d) Producing and processing food products, foodstuffs, drinks, liquors and smoking stuffs not up to hygiene standards.

e) Wholesaling on the market farm products with a residue of pesticide or chemical fertilizer exceeding the allowed limits.

4. Destruction of objects mentioned in Points f and g, Clause 2 and Points a, b, d and e, Clause 3 of this Article.

Article 2.- Violations of the regulations on water hygiene:

1. Warning or a fine of 20,000 to 50,000 VND for acts of discharging waste, waste water, bathing and washing water and other acts causing pollution of water sources used by the people in their daily life.

2. A fine of 500,000 to 2,000,000 VND for failure to observe the regulations on examining and controlling the quality of water supplied by water plants/enterprises.

3. A fine of 2,000,000 to 8,000,000 VND for one of the following acts:

a) Discharging waste by State agencies, organizations, production or business establishments, causing the pollution of water sources used by the people in their daily life.

b) Failing to ensure hygiene standards by water plants/enterprises.

4. Forcible application of measures to overcome consequences of the violations mentioned in Clause 1 and Point a, Clause 3 of this Article.

Article 3.- Violations of the regulations on labor sanitation:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Failing to organize health checks before recruitment, failing to organize periodical health checks and medical checks for employees to detect occupational diseases or failing to give medical treatment to employees suffering from occupational diseases.

b) Failing to prepare dossiers on sanitation of enterprises, health check records, occupational disease dossiers and annual or periodical registrations of labor sanitation control.

c) Having no technical medical facilities and plan for organizing prompt first aid at working places which are prone to labor accidents due to the presence of dangerous and noxious elements.

d) Failing to take disinfecting and poison neutralizing measures at places where noxious and infectious elements are present.

2. A fine of 1,000,000 to 4,000,000 VND for one of the acts:

a) Failing to take measures and install equipment for disposal of poisonous steam and gases, dust, noxious waste water, industrial discharge and other hazardous factors exceeding the allowed limits.

b) Failing to observe the regulation on labor sanitation with regard to temperature, humidity, lighting, noise, vibration, dust, steam, noxious gases and other hazardous factors.

3. A fine of 5,000,000 to 20,000,000 VND for one of the following acts:

a) Using radioactive or X-ray emitting substances without storing them at separate places or without observing the regulations on radiation safety or without disposing radioactive waste in accordance with prescriptions.

b) Failing to observe the labor sanitation regulations on radiation and magnetic electricity.

4. Suspension and forcible application of measures to overcome the consequences of the violations mentioned in Clauses 2 and 3 of this Article.

Article 4.- Violations of the regulations on hygiene in construction:

1. A fine of 5,000,000 to 20,000,000 VND shall be imposed on acts of constructing, renovating or putting into use constructions not up to the hygiene standards.

2. Forcible application of measures to overcome the consequences of the violations mentioned in Clause 1 of this Article.

Article 5.- Violations of other hygiene regulations:

1. A fine of 50,000 to 200,000 VND shall be imposed on individuals for violating the regulations on the prevention and fight against epidemics and diseases.

2. A fine of 200,000 to 500,000 VND shall be imposed on violations of the regulations on ambient hygiene in offices, hospitals, schools, kindergartens and other public places.

3. A fine of 500,000 to 2,000,000 VND shall be imposed on agencies or organizations for violating the regulations on the prevention and fight against epidemics and diseases.

4. A fine of 2,000,000 to 5,000,000 VND shall be imposed on acts of manufacturing and trading in teaching aids and children�s toys which badly effect the health of pupils and children or manufacturing and trading in children�s toys banned from manufacture and trade.

5. Forcible destruction of objects mentioned in Clause 4 of this Article.

Article 6.- Violations of the regulations on trading in and use of substitutes for breast milk:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Carrying information and/or advertisements that aim to encourage breast feeding mothers to use substitutes for breast milk.

b) Conducting false information and/or advertisements on the use of substitutes for breast milk.

c) Presenting mothers who have sufficient breast milk after childbirth or members of their family with samples of goods, aimed at encouraging the use of such products as substitutes for breast milk.

d) Giving presents or donations in any form to medical personnel working in hospitals, maternity homes or other medical establishments in order to advertise the substitutes for breast milk.

2. A fine of 5,000,000 to 20,000,000 VND shall be imposed on violations of the regulations on quality and labels of substitutes for breast milk.

3. All substitutes for breast milk that fail to meet the quality standard shall be destroyed.

Article 7.- Violations of the regulations on border epidemiological control:

1. A fine of 1,000,000 to 3,000,000 VND for one of the following acts:

a) Failing to take anti-rat measures on maritime transport means when they anchor at ports.

b) Using rat-free certificates or certificates of exemption from rat killing at variance with prescriptions.

c) Passengers compartments and cargo compartments on transport means below the hygiene standards and transport means with not enough bacteria killing, insecticide and rat-killing chemicals.

d) Modifying without authorization or forging epidemiological control certificates.

e) Exporting or importing waste matters, used articles, used transport means without declaring at the epidemiological control agency, without subjecting them to medical treatment or without epidemiological control certificates issued by the epidemiological control agency.

f) Entry transport means failing to give signals asking for an epidemiological check.

2. A fine of 3,000,000 to 9,000,000 VND for one of the following acts:

a) Concealing the actual situation of epidemiological hygiene which must be checked, or wiping out evidences of epidemics.

b) Transporting human corpses, remains, and other special objects such as microbes, biological items, tissues, organs or parts of human body, blood and blood constituents across the border without being checked and granted certificates by the epidemiological control agency.

3. A fine of 10,000,000 to 30,000,000 VND for one of the following acts:

a) Failing to make the prescribed epidemiological control declarations by the transport means owners at the epidemiological control agency in order to conduct the epidemiological control before their entry or exit.

b) Refusing to submit to epidemiological control or to implement the requirements of epidemiological control officials by persons who are subject to epidemiological control.

c) Discharging ship-pressing water, garbage, wastes containing germs and harzadous elements before the epidemiological control agency takes medical treatment measures.

Section B - ADMINISTRATIVE VIOLATIONS OF THE REGULATIONS ON DISEASE EXAMINATION AND TREATMENT; FORMS AND LEVELS OF SANCTION

Article 8.- Violations of the regulations on the use of certificates of qualification and conditions for establishing disease examination and treatment establishments (hereafter referred to as certificates of qualification and conditions for practice):

1. A fine of 200,000 to 1,000,000 VND for one of the following acts:

a) Medical establishments having addresses other than defined in the certificates of qualification for practice or having no signboard as prescribed.

b) Failing to ensure the necessary technical conditions and equipment as prescribed.

c) Failing to open statistical books, or to keep books of medication prescriptions and lists of poisons and psychotropic drugs.

2. A fine of 3,000,000 to 12,000,000 VND for one of the following acts:

a) Conducting medical practice beyond one�s professional capability or not in conformity with the area of practice defined in the certificate of qualification and conditions for practice.

b) Allowing another person to use diplomas of medical doctor, the certificates of medical practice or the certificate of qualification and conditions for practice.

3. A fine of 5,000,000 to 15,000,000 VND shall be imposed on acts of giving medical examination and treatment or medication prescriptions without certificate of qualification and conditions for practice issued by the competent health agency.

4. Suspension of acts mentioned in Clause 3 and forfeiture of the right to use the certificate of qualification and conditions for practice with regard to violations prescribed in Clause 2 of this Article.

Article 9.- Violations of the regulations on medical profession:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Giving medication prescriptions which are not appropriate to the disease but which have not yet caused serious consequences to the health and life of the patient.

b) Failing to observe the regulations on sterilization and bacteria-killing in the course of acupuncture, injection, pricking, surgery and other methods used for medical examination and treatment.

2. A fine of 2,000,000 to 8,000,000 VND for one of the following acts:

a) Failing to observe the regulations on medical technical profession.

b) Giving medication prescriptions and selling drugs besides the quantity prescribed for emergency (except for medical examination and treatment by methods of traditional national medicine).

c) Using medical instruments of poor quality for medical examination and treatment.

3. A fine of 5,000,000 to 15,000,000 VND for acts of applying medical examination and treatment methods or using medical instruments and pharmaceuticals not yet permitted by the Ministry of Health.

4. Forfeiture of the right to use the certificate of qualification and conditions for practice for violations mentioned in Clause 3 of this Article.

Article 10.- Violations of other regulations on medical examination and treatment:

1. A fine of 200,000 to 1,000,000 VND for one of the following acts:

a) Failing to take part in the medical activities for primary health care and popularization of measures of health protection, disease prevention and treatment among the population at the request of the local health authorities.

b) Failing to observe the regime of periodical reports to the health agencies directly managing the professional and technical operations of the establishments.

c) Failing to report to the local health authorities when discovering persons having contracted sexually transmitted diseases including AIDS or addicted to drugs.

d) Failing to take measures for controlling as prescribed persons having contracted serious infectious diseases.

2. A fine of 500,000 to 3,000,000 VND for acts of failing to report to the State health agencies when discovering infectious diseases that must be quarantined, strange diseases or collective contamination in order to promptly solve the consequences.

3. A fine of 3,000,000 to 10,000,000 VND for one of the following acts:

a) Making advertisements not in accordance with one�s professional capability and area of practice defined in the certificate of qualification and conditions for practice.

b) Failing to comply with the mobilization order of the competent health agency when natural calamities or epidemics break out.

Article 11.- Violations of the regulations on qualification and conditions for massage service:

1. A fine of 50,000 to 200,000 VND for one of the following acts:

a) Having no signboard at the massage room.

b) Failing to dress and wear name cards as required.

2. A fine of 200,000 to 500,000 VND for one of the following acts:

a) Massage beds not up to the required standards.

b) Failing to install emergency buzzers.

c) Failing to ensure lighting and hygienic standards required for massage rooms.

d) Failing to satisfy the requirements on floor space or partition of massage rooms.

3. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Having no emergency medicine chest as prescribed.

b) Failing to meet the requirements on exit and/or entry doors of massage rooms.

c) Failing to observe the regulations on professional technique of massage practitioners.

d) Practicing massage not at the prescribed place.

4. Forms of additional sanction and other measures:

a) Forcible application of measures to overcome the consequences of acts prescribed in Clauses 1, 2 and Points a, b, Clause 3 of this Article.

b) Forfeiture of the right to use the certificate of professional massage service for violations defined in Point c, Clause 3 of this Article.

Article 12.- Violations of the regulations on medical insurance:

1. A fine of 50,000 to 200,000 VND for acts of using the medical insurance card of another person or modifying without authorization the medical insurance card.

2. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Abusing position and powers to use medical the insurance card for personal interests.

b) Employers failing to buy or cheating in making dossiers for buying compulsory medical insurance cards for their employees.

3. A fine of 5,000,000 to 20,000,000 VND for acts of cheating in making vouchers and paying for expenditures not in accordance with regulations, thus causing losses to the medical insurance fund, but not seriously enough to be examined for penal liability.

Article 13.- Violations of the regulations on HIV/AIDS prevention and fight:

1. Warning or a fine of 50,000 to 200,000 VND for one of the following acts:

a) A HIV/AIDS infected person failing to declare the infection in the medical control form when entering Vietnam.

b) Failing to immediately inform his/her spouse of his/her HIV/AIDS infection when it is detected.

2. A fine of 200,000 to 800,000 VND for one of the following acts:

a) Disclosing without authorization confidential data about a test and test results to other person(s) but not yet causing serious consequences.

b) Violations of the regulations on keeping secret the names, ages, addresses and photographs of those who are infected with HIV/AIDS but not yet causing serious consequences.

c) Broadcasting on the mass media the names, ages, addresses or photographs of HIV/AIDS infected persons without their consent or their relatives� consent after their death.

d) Refusing to provide HIV/AIDS infected persons with medical examination and treatment.

e) HIV/AIDS-infected persons deliberately doing jobs that they are not allowed to do.

f) An employer failing to transfer HIV/AIDS infected persons to other jobs from jobs that they are not allowed to do.

3. A fine of 500,000 to 2,000,000 VND for violations of the regulations on blood transfusion, sterilization, bacteria-killing and other regulations on professional treatment of HIV/AIDS infection.

Section C - ADMINISTRATIVE VIOLATION OF THE REGULATIONS ON PHARMACY; FORMS AND LEVELS OF SANCTION

Article 14.- Violations of the regulations on criteria and conditions for pharmaceutical practice:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Trading in pharmaceuticals without certificates of qualification and conditions for setting up pharmaceutical establishments (hereafter referred to as certificates of qualification and conditions for pharmaceutical practice).

b) Allowing another person to use the certificate of qualification and conditions for pharmaceutical practice and other professional diplomas or certificates.

c) Drug sellers not qualified for the job as prescribed by the Ministry of Health.

d) Material and technical bases equipped for the manufacture and sale of pharmaceuticals not conforming to the regulations of the Ministry of Health.

e) Drugstore owners are absent when their drugstores are open.

f) Wholesale-dealing in drugs by drugstores.

2. Forfeiture of the right to use the certificate of qualification and conditions for pharmaceutical practice shall be applied to violations mentioned in Point b, Clause 1 of this Article.

Article 15.- Violations of the regulations on drug manufacture:

1. A fine of 3,000,000 to 10,000,000 VND for one of the following acts:

a) Manufacturing drugs without certificates of qualification and conditions for pharmaceutical practice.

b) Manufacturing veterinary drugs which are similar to human drugs with their labels not printed with the word "For animals".

2. A fine of 5,000,000 to 15,000,000 VND for one of the following acts:

a) Manufacturing drugs through improper processes or without monitoring records.

b) Manufacturing drugs not according to approved formulas.

c) Manufacturing drugs without a registration number issued by the competent health agency.

d) Manufacturing eastern medicines from materials of low quality.

3. A fine of 20,000,000 to 50,000,000 VND for one of the following acts:

a) Manufacturing drugs of low quality (not up to the quality standards).

b) Manufacturing western medicines from materials not yet subject to examination.

4. Forfeiture of the right to use certificates of qualification and conditions for pharmaceutical practice shall be applied to violations mentioned in Clause 3 of this Article.

5. Forcible destruction of drugs for violations mentioned in Points b, c, d Clauses 2 and 3 of this Article.

Article 16.- Violations of the regulations on preservation of drugs and materials for the production of drugs:

A fine of 1,000,000 to 4,000,000 VND for one of the following acts:

a) Failing to satisfy technical requirements for preservation to ensure the quality of drugs and materials for drug production.

b) Failing to keep technical records and books on the quantities of drugs and materials received and issued for drug production in accordance with regulations.

Article 17.- Violations of the regulations on trading, export and import of drugs and materials for drug production:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Selling the wrong drugs but not yet causing serious consequences.

b) Selling without a doctor�s prescription or not according to prescriptions drugs that require a doctor�s prescription.

2. A fine of 2,000,000 to 5,000,000 VND for one of the following acts:

a) Trading in materials for the production of western medicines without certificates of qualification and conditions for pharmaceutical practice.

b) Trading in drugs of unidentified sources of production or with original containers no longer intact.

c) Trading in drugs which are not included in the list of drugs allowed for circulation by the Ministry of Health, or drugs having no registration number.

3. A fine of 5,000,000 to 20,000,000 VND for one of the following acts:

a) Trading drugs of low quality (not up to the quality standards) or drugs the usage date of which has expired.

b) Importing drugs or materials for drug production with their containers no longer intact.

4. A fine of 20,000,000 to 60,000,000 VND for one of the following acts:

a) Exporting and/or importing drugs or materials for drug production, which are not included in the list prescribed by the Ministry of Health.

b) Importing for drug production drugs or materials, which have already been declared banned from circulation on the market by the producing country.

5. Forcible destruction of drugs for violations mentioned in Point b, Clause 4 of this Article.

6. Seizure of drugs and materials for drug production shall be applied to violations mentioned in Clause 3 of this Article.

7. Forfeiture of the right to use certificates of qualification and conditions for pharmaceutical practice shall be applied on violations mentioned in Points a and b, Clause 4 of this Article if such violations involve aggravating factors.

Article 18.- Violations of the regulations on poisons, addictive drugs, psychotropic drugs, radioactive drugs:

1. A fine of 2,000,000 to 8,000,000 VND shall be imposed on acts of writing prescribing and using poisons, addictive drugs, psychotropic drugs, radioactive drugs not in conformity with regulations issued by the Ministry of Health but not yet causing serious consequences.

2. A fine of 5,000,000 to 20,000,000 VND shall be imposed on acts of manufacturing, preparing, preserving and trading in poisons, addictive drugs, psychotropic drugs or radioactive drugs not in conformity with regulations issued by the Ministry of Health.

3. Forfeiture of the right to use certificates of qualification and conditions for pharmaceutical practice shall be applied to violations mentioned Clauses 1 and 2 of this Article.

4. With regard to violations of the regulations on manufacturing and/or trading in poisons, addictive drugs, psychotropic drugs, if there exist all factors for establishing crime, the dossiers, material evidences and means of violation shall be transferred to the investigation agency for examination of penal liability.

Article 19.- Violations of the regulations on information, advertisement and labels of drugs:

1. A fine of 2,000,000 to 8,000,000 VND shall be imposed on one of the following acts:

a) Conducting information and advertisement untrue to the properties and effect of the drug.

b) Conducting information and advertisement of drugs without permit from the competent health agency.

c) Using drugs label not ratified by the competent health agency or printing drug label not identical to the approved pattern.

d) Imitating labels of registered drugs being circulated on the market.

e) Failing to print drug labels in Vietnamese for domestically produced drugs, or failing to print the name and address of the producer.

f) Failing to print the expiry date of the drug.

2. Seizure of imitated drug labels and/or drugs with imitated labels shall be applied to violations mentioned in Points c, d and e, Clause 1 of this Article;

3. Forfeiture of the right to use the certificates of qualification and conditions for pharmaceutical practice shall be applied to violations mentioned in Points a and b, Clause 1 of this Article if such violations involve aggravating factors.

Article 20.- Acts of manufacturing and trading in fake drugs:

When detecting acts of manufacturing and trading in fake drugs, the person with competence to handle the case shall have to make a record, temporarily seize the material evidences and means used for the violation, the certificate of qualification and conditions for pharmaceutical practice, establishment licenses and business licenses, and then transfer the dossiers and material evidences and means used for the violation to investigation agency of the examination for penal liability in accordance with provisions of law.

Article 21.- Violations of the regulations on cosmetics:

1. A fine of 500,000 to 2,000,000 VND for one of the following acts:

a) Trading in and manufacturing cosmetics without certificates of qualification and conditions for business issued by the competent health agency.

b) Material base equipped not in accordance with regulations issued by the Ministry of Health.

c) Imitating or failing to register cosmetics labels.

d) Using cosmetics labels not approved by the competent health agency or printing labels not identical to the approved ones.

e) Failing to specify on the cosmetics labels the date of manufacture or the expiry date and other information about the cosmetics: components, instructions for use and preservation in accordance with regulations issued by the Ministry of Health.

2. A fine of 2,000,000 to 5,000,000 VND shall be imposed on acts of manufacturing and trading in soaps, toothpaste, talc and other personal items, that are not up to the hygiene standards.

3. A fine of 2,000,000 to 8,000,000 VND for one of the following acts:

a) Manufacturing cosmetics without registration number issued by the competent health agency.

b) Manufacturing cosmetics from materials not yet examined.

c) Manufacturing cosmetics not in conformity with the approved formula.

d) Failing to satisfy the technical requirements to ensure the quality safety of cosmetics.

e) Trading in cosmetics of unidentified production sources not up to the quality standards, beyond the expiry date or cosmetics which have been declared banned from circulation on the market by the producing country.

4. A fine of 5,000,000 to 15,000,000 VND for one of the following acts:

a) Manufacturing cosmetics which are below the quality standards.

b) Importing cosmetics or materials for cosmetics production which have been declared banned from circulation on the market by the producing country.

c) Importing and trading in cosmetics with containers no longer intact.

5. Forcible destruction of cosmetics shall be imposed on violations mentioned in Points b, c, d and e, Clauses 2 and 3 and Points a and b, Clause 4 of this Article.

Chapter II

COMPETENCE TO IMPOSE SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS

Article 22.- The competence of the State medical inspectorate to impose sanctions:

1. An Inspector for hygiene, medical examination and treatment and pharmaceutical practice, while performing his/her duty within his/her jurisdiction, shall have the competence to issue warnings, impose fines up to 200,000 VND, seize the material evidences and means used for violation valued at up to 500,000 VND, and apply other measures provided for in Points a, b and d, Clause 3, Article 11 of the Ordinance on the Handling of Administrative Violations, except for forcible compensation for damage.

2. The Chief Inspector of the provincial Health Service can impose fines of up to 10,000,000 VND, forfeit the right to use certificates of qualification and conditions for practice according to his/her competence; issue decisions to stop the violation and request the competent agency to forfeit the right to use the permits for establishing an enterprise or company, the certificate of registration for under-prescribed capital business, and apply other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance on the Handling of Administrative Violations.

3. The Chief Inspector of the Ministry of Health can impose fines up to 20,000,000 VND, forfeit the right to use certificates of qualification and conditions for practice according to his/her competence; issue decisions to stop the violation and request the competent agency to forfeit the right to use the permit for establishing an enterprise or company the certificate of registration for under-prescribed capital business and apply supplementary forms of sanction and other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance on the Handling of Administrative Violations.

Article 23.- Sanctioning competence of the President of the People�s Committee at all levels:

1. The President of the People�s Committee of commune, ward or district town can impose warnings, fines of up to 200,000 VND, seize the material evidences and means used for violations valued at up to 500,000 VND, order compensations of up to 500,000 VND for damage caused by the administrative violation, suspend the acts causing the pollution of the living environment, the spread of epidemics and diseases and destroy matters harmful to human health.

2. The President of People�s Committee of district, precinct, township or provincial city can impose warnings or fines of up to 10,000,000 VND, decide the application of supplementary forms of sanction and other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance on the Handling of Administrative Violations; except for the forfeiture of the right to use permits issued by the higher State agencies in which case the President of the People�s Committee at district level shall issue a decision to stop the violation and propose the competent State agency to revoke the permit.

3. The President of the People�s Committee of the province or city directly under the Central Government can impose warnings or fines of up to 100,000,000 VND, apply supplementary forms of sanction and other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance on the Handling of Administrative Violations; except for the forfeiture of the right to use permits issued by the higher State agencies in which case the President of the People�s Committee at provincial level shall issue a decision to stop the violation and propose the competent State agency to revoke the permit.

Article 24.- The sanctioning competence of other agencies:

1. In addition to persons defined in Articles 22 and 23 of this Decree, those persons who have competence to impose sanctions according to the Ordinance of the Handling of Administrative Violations, when discovering an administrative violation defined in this Decree that fall within their respective jurisdiction and geographical area, can impose sanctions but must observe the provisions of Articles 46, 47 and 48 of the Ordinance on the Handling of Administrative Violations.

2. If an administrative violation falls within the competence of several agencies, such violation shall be handled by the agency that is the first to take up the case.

Chapter III

PROCEDURES, PRINCIPLES AND MEASURES FOR IMPOSING SANCTIONS

Article 25.- Warnings:

1. Warnings shall be served to individuals and/or organizations that have committed for the first time minor administrative violations which involve extenuating factors.

2. The decision on warnings shall be made in writing; when deemed necessary, the agency with sanctioning competence shall notify the administration of the locality or agency or organization where the violator resides or works.

Article 26.- Procedures and measures to impose fines:

1. Upon detection of an administrative violation, the person with sanctioning competence shall promptly make a record, except for cases requiring only simple procedures. The content of and procedures for making a record shall conform with Article 47 of the Ordinance on the Handling of Administrative Violations.

2. Within 15 days from the date of making the record, the person with sanctioning competence shall issue a decision on sanction clearly stating the provisions and name of the legal document which have been violated, the level of liability and the form of sanction to be imposed in accordance with Article 48 of the Ordinance on the Handling of Administrative Violations.

The Ministry of Health shall uniformly set the model form of record, the model form of sanctioning decision for each field of medical management.

The Ministry of Finance shall uniformly set the model form of receipts, issue and manage the fining receipts.

3. Individuals and organizations that commit administrative violations in the field of State management over medicine and are fined shall have to pay fines at the places defined in the sanctioning decisions and shall be given fining receipts. The persons who issue decisions shall not be entitled to collect the fines on the spot.

4. Within 5 days from the date of receiving the sanctioning decision, the sanctioned individual or organization that deliberately disobey the decision shall be forced to comply with the sanctioning decision in accordance with Article 55 of the Ordinance on the Handling of Administrative Violations.

The agency, organizations or lawful representative of the sanctioned shall have to strictly comply with the coercive measures taken by the agency that has issued the sanctioning decision.

Article 27.- Forfeiture of the right to use permit and revocation of permit:

1. The right to use permit for establishing an enterprise, the certificate of qualification and conditions for practice and the business license granted by the State competent agencies to individuals or organizations to conduct business activities may be forfeited of if the violations of the regulations is directly related to the use of the permit or license.

2. The Chief State Inspector of the medical service (inspection on hygiene, medical examination and treatment, pharmaceutical practice) can forfeit the right to use certificates of qualification and conditions for practice and propose to the agency with competence to issue permits for establishment, certificates of registration of business the following:

a) Where the violator is allowed to continue his/her professional practice, his/her right to use the certificate of qualification and conditions for practice shall be forfeited for a given period of time.

b) In serious cases where the violator is not allowed to continue his/her professional practice, his/her right to use the certificate of qualification and conditions for practice shall be indefinitely forfeited.

c) To propose to the agency with competence to grant the permit of establishment and business licenses to withdraw such permits and licenses in the following cases:

- Permits and licenses are granted beyond competence.

- The contents of permits and licenses are contrary to the provisions of law.

Article 28.- Procedures for the application of other administrative measures:

1. State agencies and persons having sanctioning competence to impose sanctions stipulated in Articles 22, 23 and 24 of this Decree shall have to base themselves on the provisions of law and the extent of the actual damage caused by such administrative violations when issuing decisions on application of other administrative measures.

2. Where material objects which may have harmful effects on human health must be destroyed immediately, when enforcing the destruction, records must be made signed by the sanctioned person, the person who has issued the sanctioning decisions and witnesses. Where objects which may have harmful effects on human health must be destroyed but not necessarily right away such objects must be sealed and a council for the destruction shall be set up.

Article 29.- Principles of applying the forms of sanction:

1. In addition to the main forms of sanction: warning and fine, supplementary forms of sanction and other administrative measures may be applied in accordance with Article 11 of the Ordinance on the Handling of Administrative Violations.

2. The main forms of administrative sanction can be applied separately, the supplementary forms of sanction and other administrative measures cannot be applied separately but together with the main form(s) of sanction.

3. When a fine is imposed, the specific amount of the fine against an administrative violation shall be the average amount in the fine bracket prescribed for such violation; if the violation involves extenuating factors, the amount of fine may be reduced but not lower than the minimum in the fine bracket; if the violation involves aggravating factors, the in fine may be increased but not more than the maximum amount of the fine bracket.

4. The sanctioned organization must comply with the sanctioning decision, and at the same time identify the faults of its members who directly committed the administrative violation while performing their assigned duties for examination of discipline liability and the payment of compensation for damage in accordance with the provisions of law.

Chapter IV

COMMENDATION AND HANDLING OF VIOLATIONS, COMPLAINTS AND DENUNCIATIONS

Article 30.- Commendation:

Organizations and individuals that have merits in supplying information, detecting, preventing, handling administrative violations in the field of medicine shall be commended in accordance with the common regime of commendation and reward of the State.

Article 31.- Handling of violations:

If an organization or individual with sanctioning competence commits violations they shall be disciplined or examined for penal liability; depending on the nature and extent of their violations, if damage is caused to other organizations and individuals, compensations must be paid.

Article 32.- Re-examination of sanctioning decisions in case of complaints:

1. The Chief Inspector of the provincial Health Service shall review the sanctioning decision issued by the medical inspector of the provincial service when the sanctioned organization and individual file their complaints.

2. The Chief Inspector of the Ministry of Health shall review the sanctioning decision issued by the chief medical inspector of the provincial health services or the medical inspectors of the ministerial level when the sanctioned organization and individual file their complaints.

Article 33.- Procedures for handling complaints and denunciations:

1. Within 10 days, the sanctioned individual and organization or their lawful representative have the right to lodge complaints to the person that issued the sanctioning decision.

2. Within 15 days from the date of receiving complaints, the person(s) that issued the sanctioning decision(s) shall have to decide and answer in writing to the complainants.

If the complainant disagrees with the decision of settlement, he/she can lodge a complaint to the immediate superior of the person that issued the sanctioning decision within 3 days from the date of receiving the settlement decisions.

Within 20 days from the date of receiving the complaint, the head of the immediate higher agency of the person that issued the sanctioning decision shall have to decide and answer in writing to the complainant.

Complaints against the settlement of complaints by the Presidents of the province or city directly under the Central Government must be sent by the Chief Inspector of the Ministry of Health to the Minister of Health.

Within 30 days from the date of receiving such a complaint, the Minister of Health shall have to examine, conclude and answer in writing to the complainant. Within 7 days from the date of receiving the answer, the person who has issued the decision on settling the complaint shall have to comply with the decision of the Minister of Health.

In case the President of the People�s Committee of the province or city directly under the Central Government disagrees with the settlement of the Minister of Health, he/she shall have the right to lodge a complaint to the General State Inspector. Within 45 days from the date of receiving the complaint the General State Inspector shall have to consider and issue a decision on the complaint. The decision of the General State Inspector shall be final.

3. The complaint about sanctions against administrative violations shall not cause the suspension of the implementation of the sanctioning decisions.

4. Where the person in charge of settling complaints issue a decision to change the form, level and measure of sanction, or annul the previous sanctioning decision, he/she may also decide the compensation or direct repayment for damage (if any) in accordance with the provisions of law.

If the complainants disagrees with the decisions on compensation or repayment, he/she can request the Court to settle the complaint through the procedure of civil proceedings.

Chapter V

IMPLEMENTATION PROVISIONS

Article 34.- Scope of application:

This Decree shall apply to all individuals and organizations, including the foreign individuals and organizations and foreign-invested enterprises in Vietnam.

Article 35.- Legal effect:

This Decree takes effect from the date of its signing and replaces Decree No.341-HDBT of September 22, 1992 of the Council of Ministers (now the Government) promulgating the Regulation on the Handling of Administrative Violations in the Field of Medicine.

Article 36.- Responsibility for guiding the implementation of this Decree:

1. The Minister of Health shall have to guide the implementation of this Decree.

2. The Minister of Finance and the Minister of Health shall have to guide and manage the use of fines against administrative violations in the field of State management over medicine.

Article 37.- The Ministers, the Heads of the ministerial-level agencies, the Heads of the agencies attached to the Government, the Presidents of the People�s Committees of the provinces and cities directly under the Central Government shall have to implement this Decree.

On behalf of the Government

The Prime Minister

VO VAN KIET